Associate Director, Regulatory Affairs (Labeling) | Associate Director Regulatory Affairs (Labeling) FSP

Job Summary

This critical role involves joining a world-class team to manage global labeling activities, ensuring strict compliance with international regulatory standards across foundational (EU, CH, DE) and dependent markets. The Associate Director will oversee the entire labeling lifecycle, including coordinating readability testing, translations, and linguistic reviews, while managing the preparation and upload of approved labels to internal systems (e.g., Documentum, Weblabel) and external platforms (HA, ePIL). A core function is maintaining essential regulatory documents such as the Company Core Data Sheet (CCDS), US Prescribing Information (USPI), and EU Summary of Product Characteristics (SmPC). The position requires managing global labeling compliance, quality control, FDA-508 adherence, and leading the Labeling Review Committee (LRC) process. Success hinges on applying comprehensive regulatory expertise and demonstrated leadership to strategically influence therapeutic area teams and manage complex, time-sensitive global projects.